Data / Medical devices / Australia / Saluda Medical Pty. Ltd.
Saluda Medical Pty. Ltd.: FDA-registered device maker in Macquarie Park New South Wales, Australia, 1 PMA approval
Saluda Medical Pty. Ltd. is registered with the FDA (registration 3021836309) in Macquarie Park New South Wales, Australia. It lists 3 device types. The FDA files 1 PMA approval under its listings, the newest dated February 28, 2022. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3021836309
- Address
- 5 Eden Park Drive, Macquarie Park New South Wales, Australia, 2113
- Owner or operator
- Saluda Medical Pty Ltd (10061701)
- Roles
- Manufacturer, Specification developer
- First device listed
- November 14, 2019
- Registered through
- 2026
- Brand names listed
- Evoke 12C Lead Extension Kit - 55cm, Evoke 12C Percutaneous Lead Kit - 60cm, Evoke 12C Percutaneous Lead Kit - 90cm, Evoke Epidural Needle, 6.5", Evoke Intraoperative Cable Kit, Evoke Lead Adapter Kit, Evoke Spares Kit, Evoke Tunneling Tool and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Electrical, Implantable, For Incontinence | EZW | 3 | Manufacturer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Totally Implanted For Pain Relief | LGW | 3 | Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy | QRB | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 28, 2022 | P190002 | Saluda Medical Evoke SCS System | LGW | 44 | October 16, 2026 | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Spinal-Cord, Totally Implanted For Pain Relief
- All makers of Stimulator, Spinal-Cord, Totally Implanted For Relief Of Pain Due To Diabetic Neuropathy
- All makers of Stimulator, Electrical, Implantable, For Incontinence
Updated October 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.